Surgical instrument

ABSTRACT

A surgical instrument is provided which is particularly suited for use in circumcision operations, comprising a clamping and holding member adapted to be readily formed of molded plastic material and especially constructed for use in the place of circumcision operations normally involving the use of conventional hospital instruments such as a probe, scalpel, and hemostat. In a preferred form the instrument includes in combination with the clamping and holding member, a cutting member, the two members being pivotally connected together and guided in cooperative operation position, and which instrument is sufficiently inexpensive so that it can be discarded after the end of the operation thereby obviating the need of sterilization for reuse.

United States Patent Melges 1 1 Dec. 19, 1972 1541 SURGICAL INSTRUMENT [72] Inventor: Frederick J. Melges, Battle Creek,

Mich.

[73] Assignee: Rymel Corporation, Sierra Madre,

Calif.

[22] Filed: March 13, 1970 [21] Appl. No.: 19,329

Related U.S. Application Data [63] Continuation-in-part of Ser. No. 780,463, Dec. 2,

1968, Pat. No. 3,566,873

[52] U.S. Cl ..l28/305, 128/346 [51] Int. Cl. ..A6lb 17/326, A61b 17/08 [58] Field of Search ..128/305, 346;

24/248 SL. 255 SL [56] References Cited UNITED STATES PATENTS 3,461,876 8/1969 Miller, Jr ..128/346 1,918,700 7/1933 Harris ..128/305 2,747,576 5/1956 Bronstein ..l28/346 3,171,184 3/1965 Posse ....l28/346 X 3,247,852 4/1966 Schneider ..l28/346 3,323,208 6/1967 Hurley, Jr... ..128/346 X FOREIGN PATENTS OR APPLICATIONS Netherlands ..24/255 SL France ..24/248 SL [57] ABSTRACT A surgical instrument is provided which is particularly suited for use in circumcision operations, comprising a clamping and holding member adapted to be readily formed of molded plastic material and especially constructed for use in the place of circumcision operations normally involving the use of conventional hospital instruments such as a probe, scalpel, and hemostat. In a preferred form the instrument includes in combination with the clamping and holding member, a cutting member, the two members being pivotally connected together and guided in cooperative operation position, and which instrument is suffi' ciently inexpensive so that it can be discarded after the end of the operation thereby obviating the need of sterilization for reuse.

7 Claims, 9 Drawing Figures PATENTED DEC I9 1912 SHEEI 2 UF 2 INVENTOR I; I F.J. MELGES 0 7 4 5 BY ATTORNEY SURGICAL INSTRUMENT BACKGROUND OF THE INVENTION This application is a continuation-in-part of copending application Ser. No. 780,463, entitled Surgical Instrument, filed Dec. 2, 1968 by the present inventor, now US. Pat. No. 3,566,873 dated Mar. 2, I971.

The present invention deals broadly with a surgical instrument, and in its more specific phases with a disposable circumcision apparatus which may be in the form of a clamping an holding member alone, or in combination with a cutting member cooperatively and pivotally joined to same.

In carrying out circumcision operations the common practice is to use surgical'scissors to shorten the boy babys foreskin, a procedure which almost invariably causes not only a rough and crude finished job, but often leads to bleeding and the need of stitches along the cut edge. A recognition that this was far from an ideal procedure led to the development of the circumcision instrument covered in .U. S. Pat. No. 2,2l2,l33 which was and has been up to the present time the most satisfactory instrument devised, although several other non-disposable steel instruments have been proposed. That instrument, however, was expensive to produce and keeping the blade sharp presented problems. The present invention is an improvement on the noted instrument, as well as on that disclosed and claimed in the above-noted pending application, and was devised with a view to solving the noted circumcision problems as well as others which are well known but for which there have been no instruments providing wholly satisfactory commercial solutions wherein the trimming is perfectly smooth and appears when healed,.

aside from a shortened foreskin and mucosa, to be the same as though no operation had been performed. It was a recognition of the problems involved and the need of an improved disposable circumcision instrument, which led to the conception and development of the present invention. 4

SUMMARY OF THE INVENTION Accordingly, among the objects of the present invention is the provision of a wholly satisfactory, highly simplified, and easy to use circumcision instrument.

Another object is to produce a circumcision instrument which is capable of being manufactured at such a low cost, and easy initial sterilizability, that same can be used once and then discarded.

Another object is to provide a circumcision instrument with a portion which can be clamped shut to crush the foreskin at the desired point and seal the veins and arteries so as to eliminate bleeding and the need of using stitches, while at the same time the cutting portion, which is preferably part of the instrument, is pivotally mounted on the clamping portion, and is adapted to be rotated with respect to the clamping portion and thereby to sever the foreskin along the adjacent surface of the clamping portion at an upward of the crushed area.

A further object of this invention is to provide breakable latch means for the clamping and holding portion so that removing the instrument at the end of the circumcision operation will preferably require breaking this latch and thus destroying the instrument so that for the next circumcision operation a new and thoroughly sterile instrument assembly will be used, thus doing away with cleaning and re-sterilizing of the used instrument assembly, and wherein the blade of a new instrument assembly will always be unused and sharp.

A further object of the invention is to provide the cutting portion of the instrument at its end remote from its hinge end with guide means which hold same in proper shearing position relative to the clamping and holding portion.

A further object is to provide the hinged end of the cutting portion with an extension which closely fits and passes through the hinge end of the clamping portion, and wherein the outer end of said extension is provided with a flange or outward tapering wedge portion which binds the hinge end of the cutting portion onto the adjacent side of the clamping portion for improved, close fit, cutting action.

A further object of this invention is to provide a cutting portion which pivots freely with respect to the hinge of the clamping and cutting portions and which is provided with handle means for causing the knife section to pivot.

A further object of this invention is to provide the members of the clamping and holding portion with feet to elevate the assembly for easy grasping by the surgeon, and to also provide upstanding gripping tabs to facilitate operatively clamping the instrument, with one of the tabs also acting as a cutting knife stop so that the surgeon will not cut himself at the end of the foreskin severing step.

A further object of this invention is to provide the members of the clamping and holding portion with beveled jaws cooperating to form a V-shaped trough for the reception and positioning of the end of the glans penis while avoiding any injury to same during the foreskin clamping and holding step.

A further object of this invention is to provide the clamping means at each end of the instrument for positively clamping the members together in alignment while at the same time stopping the side edge of the foreskin from flowing under clamping pressure into the hinge portion and out of cutting position.

Still another object of this invention is to provide novel hinge means for the members of the clamping portion and for independently pivoting the knife portion on the clamping portion.

Still further objects and advantages of the invention will appear as the description proceeds.

BRIEF DESCRIPTION OF DRAWINGS To the accomplishment of the foregoing and related ends, the invention, then, consists of the surgical instrument hereinafter fully described and particularly pointed-out in the claims, the annexed drawings and the following description setting forth in detail certain illustrative embodiments of the invention, such disclosed embodiments illustrating, however, but several of the various ways in which the principle of the invention may be used.

In the annexed drawings:

FIG. 1 shows a top assembly view of a preferred form of the surgical instrument of the present invention in open position.

l060ll 0433 FIG. 2 shows a top assembly view similar to that of FIG. 1, but with the clamping and holding portion partially closed.

FIG. 3 shows a top assembly view similar to that of FIGS. 1 and 2, but with the clamping and holding portion completely closed and latched.

FIG. 4 is a side view of the surgical instrument assembly as taken along line lV-IV OF FIG. 3, looking in the directionof the arrows.

FIG. 5 shows a bottom or underside view of the surgical instrument assembly shown in FIGS. 1-3, with a portion broken away to show the position of the knife carrying member, as taken along the line V-V of FIG. 4, looking in the direction of the arrows.

FIG. 6 shows an end view of the surgical apparatus taken at the line VIVI of FIG. 2, looking in the direction of the arrows.

FIG. 7 shows a cross sectional view of the hinge portion of the apparatus taken at the line VII-VII of FIG. 2, looking in the direction of the arrows.

FIG. 8 shows a cross sectional view of the apparatus taken at the line VIIIVIII of FIG. 3, looking in the direction of the arrows; and

FIG. 9 shows a fragmentary view partially broken away, of a hinge assembly structure comprising another embodiment of the invention.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS Referring more particularly to FIGS. 1-4, a preferred embodiment of the surgical instrument is shown comprising a clamping and holding member 16 having a cutting member 17 mounted on top of same. Clamping member 16 has a pair of side members 18 and 19 unit joined together by means of an open side ring shaped hinge member 20. A positive hooking means is provided at the distal end of the clamping and holding member comprising a hook latch member 21 having an engaging tab 22, and a hook 23 having a small end ridge 24 at its engaging end for positive locking engagement. The hook latch member 21 is contoured to provide a constriction 25 permitting the latch to be broken open by firmly depressing the tab 22. A cooperating latch member 26 is provided at the distal end of the side member 18 having a small groove 27 adapted to engage the small end ridge 24 of the latch member 21, thereby providing a strong positive lock, as shown in FIGS. 3 and 5.

A locking means proximal to the hinge member is provided by means of a latching hook 28 and a complementary latching member 29. As shown in the drawings, the clamping and holding member may be molded to provide frames 30 and 31 including clamping jaws 32 and 33, surrounding webs 34 and 35, respectively, of reduced thickness, FIG. 1. Additionally, to increase the strength of the side member 19, transverse ribs 36 are provided. A limit tab 37 is provided adjacent the latching hook 28 and cooperates in closed position with the surface 38 of the side member 18 to serve as a stopmeans to prevent the clamped foreskin from spreading beyond the jaws of the clamping and holding member 16. Guide tabs or ears 39 and 40,- FIG. 6, are provided at the end of the hinge member 18 to maintain the clamping jaws 32 and 33 in superposed registry when the side members 18 and 19 are latched in closed position.

The clamping and holding member 16 is preferably provided on its bottom surface with feet 41, 42, 43 and 44, FIGS. 4 and 5, to maintain the instrument elevated above the surface upon which it rests, and make it easier for the surgeon to pick up and use the-instrument. The forwardmost feet 42 and 44 additionally serve as a gripping means when clamping the two side members together. Additionally, gripping tabs 45 and 46 are provided on the upper surfaces of the side members 18 and 19 to cooperate with the feet 42 and 44, respectively, as gripping tabs so that a uniform non-twisting clamping force may be applied.

The clamping edges or jaws 32 and 33 of the side members 18 and 19, FIGS. 1 and 2, are provided at their lower surface with beveled edges 47 and 48, FIG. 8, to provide a triangular prismatic shaped recess or trough 49 which serves as a guide for placing and maintaining the free end of the glans penis in the proper position, as will be described below.

The cutting member 17, FIG. 1, comprises a side member 50 having a cutting knife 51 mounted thereon by suitable means such as by metal or plastic riveting (not shown) or by adhesive or plastic welding, all of which it is intended to be considered as diagrammatically illustrated inv the drawings. The cutting side member 50 is provided at one end with a partial ringshaped member 53, as shown in FIGS. 1 and 7, and mounted on the clamping and holding member 16 by means of a partial tubular extension 54 closely fitting within the opening of the ring-shaped member 20 to stabilize them relative to each other. A flange 55 is provided on the tubular extension 54, maintaining the two structures together in a tightand stabilized axial fit while still permitting free pivotal movement of the cutting member 17. The forward end of the side member 50 is provided with a finger grip member 56 to facilitate moving the cutting member through its arc during the circumcision operation. The gripping tab 45 additionally serves as a limiting stop to prevent the cutting member 17 from going beyond its necessary movement and cutting the surgeons finger or hand.

Referring to the embodiment shown in FIG. 9, the general structure of the clamp members 60 and 61, and cutting blade member 65, the major portions of which are not shown, utilizes adifferent type of hinge means for the various members. In all other respects the structure is the same as that shown in FIGS. 1 to 8, inclusive. Referring to FIG. 9, the structure in the position shown comprises an upper side member 60, lower side member 61, and a hook 62 connected to the upper side member 60 and having a hook stop 63 at its end. The lower side member 61 has at its end a hook 64. A knife member 65 having a cutting blade 69 is provided with a cylindrical pivot pin member 66 having a top flange 67 and a bottom flange 68, which flanges maintain the assembly in axial engagement.

The assembly utilizing the hinge arrangement of FIG. 9, which may be termed a gooseneck hinge, is assembled by first sliding the hook 64 over and around the pivot pin member 66. The hook 62 is then forced over and around the hook 64 concentric with the pivot pin member 66. The resilience of the plastic material permits the hooks 62 and 64 to expand and then to retract in concentric relation to the pin 66, the assembly being held together in operable position in combination with l060ll 0434 the flanges 67 and 68 on the ends of pin 66. In operation, the pivoting of the members, the clamping procedure and the cutting procedure proceed in normal manner, as described above.

The gooseneck type of hinge as well as the hinge of FIGS. 1, 2 and 3, may additionally be used for the side members forming the clamping means even in the absence of a cutting blade means, such as when the clamping means is used with a separate knife or scalpel. In such a structure the pivot pin member 66 is omitted from the gooseneck form of the hinge and the outer hook then merely pivots over the inner hook. If desired, flanges (not shown) may be provided on the inner hook in order to maintain the two hooks in fixed axial relationship.

OPERATION OF THE CIRCUMCISION INSTRUMENT A disposable paper draping kit (not shown) including an outside protective wrapper is preferably used in the place of conventional linen or cotton drapes, with this outside wrapper used to drape the instrument table (not shown) with the sterile inside face of same up. Inside the draping kit is a first sterile sheet (not shown) which is used to drape the baby receiving table (not shown). The baby boy is placed back down on this sheet and is held on the table by the nurse who lightly keeps her elbows on the babys shoulders with the babys head between them. Her hands hold the babys legs down and spread so that the operator can readily perform the circumcision procedure. The hospital circulating nurse adds the preparation solution to the disposable medicine cup (not shown), which is part of the draping kit components along with the circumcision instrument. She also supplies the necessary hospital instruments to the instrument table, namely a probe, a hemostat, and scissors; optionally there may be tissue forceps, and a needle holder, as well as a suture and needle.

The operator then prepared the baby 5 penis with the sterile solution and drapes the baby using a second sterile circumcision sheet (not shown) having a suitable hole, through which the penis is passed and the baby is then ready for the actual circumcision operation which is carried on as follows: The operator grasps the penis and with the probe separates the excess prepuce form the glans penis. If necessary, a small dorsal slit is made in the foreskin anteriorly in order to facilitate the separation from the glans and pushing it back over the corona. After this has been done, the foreskin is returned to its previous extended position. A light is preferably used behind the penis so as to reflect the shadow of the glans penis in the foreskin. The end portion of the foreskin is then grasped at right angles to the penis with a hemostat (not shown) and stretched anteriorly. With the foreskin thus stretched the clamping member 16 is applied with the glans penis fitting into the trough-like recess 49. The side members 18 and 19 are then pushed together by grasping the tabs 42 and 45, and 44 and 46 until the proximal latching member comprising the members 28 and 29 are hooked. The members are then further pressed together until the distal clamping means comprising latching members 21 and 26 are hooked. The trough-like recess 49 during this process pockets or positions and prevents injury to the glans penis. Subsequently the cutting member 17 is pivoted by means of the finger grip member 56 until the knife reaches its limiting position in engagement with the tab 45, thereby severing the excess foreskin without injuring the glans penis which safely fits into the recess 49. After about a minute the clamping member 16 is released, preferably by breaking off the hook latch member 21 at the weakening point constriction 25, whereupon the members 18 and 19 spring open sufficiently, even with hook 28 still latched, so that the whole surgical instrument assembly 15 is free to be discarded. If it is desired to also unlatch hook 28 from 29, an opening pull to separate side members 18 and 19 will accomplish the opening of the latch proximal to the hinge end of the instrument with no difficulty.

In carrying out this procedure the skin, mucous membrane, and all blood vessels of the foreskin over the glans penis have been sealed together by the crushing action of the clamping member, with resultant sealing preventing bleeding. The sealed edge foreskin, after the circumcision instrument has been removed, is then pushed back over the corona by using the index finger and thumb of both hands. It is held in this position for a moment until the mucous membrane swells slightly causing the foreskin to remain in this position. Whether a circumcision dressing is applied, or a small piece of gauze is placed on the penis on which baciguent, or other sterile ointment, has been applied, is optional. Actually no dressing is required as there is very little, or no, bleeding. However, ointment is desirably used since it prevents the cut edge of the foreskin and the glans penis from adhering to the babys diaper. Stitches are seldom necessary, and the entire procedure normally takes less than three minutes and all materials are disposable except for the sterilizable instruments which have been supplied by the hospital.

By omitting cutting member 17 or 65, FIGS. 1 or 9, the clamping and holding member of the present surgical instrument assembly constitutes a marked improvement over previous devices of the type in that it utilizes dual positive hooking of the clamp by virtue of the structure in which a clamping means is provided at both ends of the clamping surfaces. This permits a higher precision clamping action and one which will not accidentally be released during the operation.

Although a large variety of materials may be utilized to fabricate the surgical instrument assembly of the present invention, moldable plastic materials which have the desired strength, impact resistance, and dimensional stability are preferred. Suitable materials are nylon, polypropylene, polycarbonates, polyesters, et cetera. The blade utilized for the cutting member may be formed of any suitable material such as surgical steel. Commercial razor blades of the structure shown in the drawings may also be utilized and are entirely satisfactory. They may be affixed to the cutting member by suitable means such as by metal or plastic rivets, plastic welding, or by a suitable adhesive having strong holding powers for holding the metal blade on the plastic carrier over the range of temperatures to which the assembly will be subjected in the course of sterilization, storage, or transportation.

The surgical instrument of the present invention has a number of advantages over those previously known. First, it is provided with positive clamp locks on both 'l060ll 0435 ends of the clamping jaws to provide positive precision clamping. Second, it is provided with a novel hinge means for pivotally hinging the side members of the clamp, and additionally providing pivotal means for the cutting assembly. Additionally a triangular prismatic recess is provided for positioning and protecting the tip of the glans penis during the operation.

While only a few forms of the invention have been shown and described, other forms within the spirit and scope of the invention will now be apparent to those skilled in the art. Therefore, the embodiments shown in the drawings are to be considered as merely setting forth the surgical instrument invention for illustrative purposes, and are not intended to limit the scope of the invention herein described, shown and claimed. It is further to be noted that while directional terms have been used, same are not to be construed as a limitation of the invention since such use has been availed of to better describe the invention as used and in the position illustrated in the drawings.

Other methods of applying the principle of my invention may be employed instead of those explained, change being made as regards the article and combinations herein disclosed, provided the means and features stated by any of the following claims or the equivalent of such stated means and features be employed.

1 therefore particularly point out and distinctly claim as my invention:

1. A surgical instrument of the character described particularly adapted for use in the conducting of circumcision operations, which comprises an integral clamping member having two arms with clamping faces longitudinally abuttable with each other, a partial ringshaped hinge means integrally connected to one end of each of said arms and permitting them to pivot with respect to each other while spring-biasing them to a normally open position, clamping lock means at the end of said clamping faces proximal to said hinge means, additional clamping lock means provided at the end of said clamping faces distal to said hinge means, thereby permitting said arms to be locked in positive clamping engagement at both ends of said clamping faces, and a cutting member pivotally mounted at the hinge means of said clamping member, and wherein said cutting member has an extension fitting extending through the partial ring-shaped hinge means of said clamping member, and having a flange at the end of said extension for retaining said extension within the partial ring-shaped member of said clamping means.

2. A surgical instrument as set forth in claim 1, wherein at least one of said arms has guide means for holding said arms in clamping alignment during the closing and latching of same.

3. A surgical instrument as set forth in claim 1, wherein said guide means is a pair of guiding ears positioned on opposite sides of one of said arms adjacent said latching means,

4. A surgical instrument as set forth in claim 1, wherein stop means is provided adjacent said proximal clamping lock means, thereby preventing the foreskin from being pushed toward said hinge means out of the clamping area of said clamping member when the latter is being clamped.

5. surgical instrument according to claim 1, wherein said arms are beveled at said clamping faces thereby providing a trough-like recess adapted to position and protect the glans penis during the operation.

6. A surgical instrument according to claim 1, wherein said clamping means has supporting feet to elevate same for ease of grasping.

7, A surgical instrument of the character described particularly adapted for use in the conducting of circumcision operation, which comprises a clamping member having two arms with clamping faces longitudinally abuttable with each other, hinge means comprising a circular hook provided in one of said arms and a mating circular hook provided at the other arm pivotally engaging the hook of said first arm, one of said hooks being slidably mounted over the other in coplanar and coaxial arrangement, clamping lock means at the end of said clamping faces proximal to said hinge means, and additional clamping lock means provided at the end of said clamping faces distal to said hinge means, thereby permitting said arms to be locked in positive clamping engagement at both ends of said clamping faces, and a cutting member having a pivot pin member at one end pivotally and coaxially engaged by the hook of said first arm, said pivot pin member being provided with flanges at the ends thereof, thereby maintaining said hooks in axial relationship thereto, whereby said two arms and said cutting member are pivotal with relation to each other.

l060ll 0436 

1. A surgical instrument of the character described particularly adapted for use in the conducting of circumcision operations, which comprises an integral clamping member having two arms with clamping faces longitudinally abuttable with each other, a partial ring-shaped hinge means integrally connected to one end of each of said arms and permitting them to pivot with respect to each other while spring-biasing them to a normally open position, clamping lock means at the end of said clamping faces proximal to said hinge means, additional clamping lock means provided at the end of said clamping faces distal to said hinge means, thereby permitting said arms to be locked in positive clamping engagement at both ends of said clamping faces, and a cutting member pivotally mounted at the hinge means of said clamping member, and wherein said cutting member has an extension fitting extending through the partial ring-shaped hinge means of said clamping member, and having a flange at the end of said extension for retaining said extension within the partial ring-shaped member of said clamping means.
 2. A surgical instrument as set forth in claim 1, wherein at least one of said arms has guide means for holding said arms in clamping alignment during the closing and latching of same.
 3. A surgical instrument as set forth in claim 1, wherein said guide means is a pair of guiding ears positioned on opposite sides of one of said arms aDjacent said latching means.
 4. A surgical instrument as set forth in claim 1, wherein stop means is provided adjacent said proximal clamping lock means, thereby preventing the foreskin from being pushed toward said hinge means out of the clamping area of said clamping member when the latter is being clamped.
 5. A surgical instrument according to claim 1, wherein said arms are beveled at said clamping faces thereby providing a trough-like recess adapted to position and protect the glans penis during the operation.
 6. A surgical instrument according to claim 1, wherein said clamping means has supporting feet to elevate same for ease of grasping.
 7. A surgical instrument of the character described particularly adapted for use in the conducting of circumcision operation, which comprises a clamping member having two arms with clamping faces longitudinally abuttable with each other, hinge means comprising a circular hook provided in one of said arms and a mating circular hook provided at the other arm pivotally engaging the hook of said first arm, one of said hooks being slidably mounted over the other in coplanar and coaxial arrangement, clamping lock means at the end of said clamping faces proximal to said hinge means, and additional clamping lock means provided at the end of said clamping faces distal to said hinge means, thereby permitting said arms to be locked in positive clamping engagement at both ends of said clamping faces, and a cutting member having a pivot pin member at one end pivotally and coaxially engaged by the hook of said first arm, said pivot pin member being provided with flanges at the ends thereof, thereby maintaining said hooks in axial relationship thereto, whereby said two arms and said cutting member are pivotal with relation to each other. 